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Accelerated iTBS for PTSD and Depression

2026年9月15日 更新者：Lawson Research Institute of St. Joseph's

Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study

The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).

The main questions this study aims to answer are:

  1. Can participants complete six short brain stimulation sessions per day for five days?
  2. Is this treatment schedule safe and tolerable for participants?
  3. What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?

Participants will:

  1. Complete health screening and baseline assessments.
  2. Receive six short sessions of magnetic brain stimulation per day for five days.
  3. Have their brain activity measured using an EEG recording.
  4. Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a single-arm, open-label pilot feasibility study of accelerated intermittent theta burst stimulation, also called accelerated iTBS, in adults with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). The study is designed to assess whether an accelerated iTBS schedule can be delivered safely, tolerably, and feasibly in a clinical setting. The main focus is feasibility, including recruitment, treatment adherence, participant retention, safety, tolerability, and participant acceptability. About 12 to 16 participants will receive active accelerated iTBS. Treatment will include six short stimulation sessions per day over five consecutive days, for a total of 30 sessions. The study will also collect exploratory information over time on depression symptoms, PTSD symptoms, anxiety, daily functioning, quality of life, and brain activity measured by EEG. Because this is a small pilot study, the analysis will be mainly descriptive. The results will help refine study procedures and guide the design of a larger future clinical trial.

研究类型

介入性

注册 (估计的)

16

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 加拿大
    • Ontario
      • London、Ontario、加拿大、N6C 0A7
        • 招聘中
        • St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
        • 接触：
        • 接触：
        • 首席研究员：
          • Radhika Kelkar, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).
  • Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and/or PCL-5 score ≥33 (probable PTSD).
  • On a stable pharmacologic and/or psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.
  • Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London/Parkwood Institute.
  • Sufficient English proficiency to complete consent and study assessments.

Exclusion Criteria:

  • Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal/electronic implants contraindicated for transcranial magnetic stimulation.
  • Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.
  • Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression/PTSD episode.
  • Enrollment in another interventional trial.
  • Inability to comply with the study schedule.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Accelerated iTBS
Participants will receive active accelerated intermittent theta burst stimulation (iTBS). Treatment will consist of six short stimulation sessions per day delivered over five consecutive days, for a total of 30 sessions.
设备：Accelerated intermittent theta burst stimulation
Accelerated intermittent theta burst stimulation, also called accelerated iTBS, is a non-invasive magnetic brain stimulation intervention. Stimulation is delivered to the left dorsolateral prefrontal cortex using a transcranial magnetic stimulation system. Participants receive six short sessions per day over five consecutive days.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Recruitment rate
大体时间：Study recruitment period, up to 12 months
Recruitment rate will be assessed as the number of participants enrolled per month during the active recruitment period.
Study recruitment period, up to 12 months
Consent rate
大体时间：Study recruitment period, up to 12 months
Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.
Study recruitment period, up to 12 months
Treatment adherence
大体时间：Treatment Days 1 through 5
Treatment adherence will be assessed as the percentage of scheduled accelerated iTBS sessions completed during the 5-day treatment course.
Treatment Days 1 through 5
Retention through Week 12 follow-up
大体时间：Baseline through Week 12
Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.
Baseline through Week 12
Adverse events
大体时间：Treatment Days 1 through Week 12
Adverse events will be assessed as the proportion of participants who experience one or more adverse events during treatment and follow-up.
Treatment Days 1 through Week 12
Serious adverse events
大体时间：Treatment Days 1 through Week 12
Serious adverse events will be assessed as the proportion of participants who experience one or more serious adverse events during treatment and follow-up.
Treatment Days 1 through Week 12
Discontinuations due to adverse events
大体时间：Treatment Days 1 through Week 12
Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.
Treatment Days 1 through Week 12
Participant satisfaction with accelerated iTBS
大体时间：Week 2, Week 5, and Week 12
Participant satisfaction will be assessed using a 5-point Likert satisfaction rating scale. Scores range from 1 to 5, with higher scores indicating greater satisfaction.
Week 2, Week 5, and Week 12
Participant feedback on accelerated iTBS
大体时间：Week 2, Week 5, and Week 12
Participant feedback will be assessed using brief feedback questions about the accelerated iTBS treatment schedule and overall study experience. Responses will be summarized descriptively.
Week 2, Week 5, and Week 12

次要结果测量

结果测量
措施说明
大体时间
Exploratory change in clinician-rated depression symptom severity measured by HAMD-17
大体时间：Baseline, Week 2, Week 5, and Week 12
Clinician-rated depression symptom severity will be assessed using the Hamilton Depression Rating Scale-17. Total scores range from 0 to 52, with higher scores indicating greater depression symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in self-reported depression symptom severity measured by PHQ-9
大体时间：Baseline, Week 2, Week 5, and Week 12
Self-reported depression symptom severity will be assessed using the Patient Health Questionnaire-9. Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in self-reported PTSD symptom severity measured by PCL-5
大体时间：Baseline, Week 2, Week 5, and Week 12
Self-reported PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5
大体时间：Baseline, Week 2, and Week 12
Clinician-rated PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5. Total symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Baseline, Week 2, and Week 12
Exploratory change in anxiety symptom severity measured by GAD-7
大体时间：Baseline, Week 2, Week 5, and Week 12
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 item Scale. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in cognitive function measured by MoCA
大体时间：Baseline, Week 2, Week 5, and Week 12
Cognitive function will be assessed using the Montreal Cognitive Assessment. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Baseline, Week 2, Week 5, and Week 12
Exploratory change in functioning and disability measured by WHODAS 2.0
大体时间：Baseline, Week 2, Week 5, and Week 12
Functioning and disability will be assessed using the WHO Disability Assessment Schedule 2.0
Baseline, Week 2, Week 5, and Week 12
Exploratory change in quality of life measured by Q-LES-Q-SF
大体时间：Baseline, Week 2, Week 5, and Week 12
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form.
Baseline, Week 2, Week 5, and Week 12
Baseline clinical global severity measured by CGI-S
大体时间：Baseline
Clinical global severity will be assessed using the Clinical Global Impression-Severity scale. Scores range from 1 to 7, with higher scores indicating greater illness severity.
Baseline
Exploratory change in clinical global improvement measured by CGI-I
大体时间：Week 2, Week 5, and Week 12
Clinical global improvement will be assessed using the Clinical Global Impression-Improvement scale. Scores range from 1 to 7, with lower scores indicating greater clinical improvement.
Week 2, Week 5, and Week 12
Exploratory change in resting-state EEG alpha power
大体时间：Baseline, Treatment Day 1, and Treatment Day 5
Resting-state EEG alpha power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
Baseline, Treatment Day 1, and Treatment Day 5
Exploratory change in resting-state EEG gamma power
大体时间：Baseline, Treatment Day 1, and Treatment Day 5
Resting-state EEG gamma power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
Baseline, Treatment Day 1, and Treatment Day 5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Lawson Research Institute of St. Joseph's

调查人员

  • 首席研究员：Radhika Kelkar, MD、St. Joseph's Health Care London, Parkwood Institute, Finch Family Mental Health Care Building

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月26日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AiTBS-PTSD-MDD--001
  • 127851 (其他标识符：Western HSREB Project ID)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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